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Karen R. Zimm, Ph.D.Jeremy Banaszewski, M.S., Temple University Abstract This review article discusses the recent developments surrounding FD&C Red No. 3, a synthetic colorant utilized in various dosage forms. The significance of colorants in product identification and the implications of the FDA’s recent regulatory actions are examined. This article also analyzes historical perspectives, scientific evidence […]
Ronald D. Snee, PhDSnee Associates, LLC In the pharmaceutical world we talk a lot about Data Integrity. The FDA (2016) published A guidance for industry on matters involving data integrity. We hear analysts talking about Data Quality. Legal proceedings often question the “Chain of Custody of the Data.” Metadata is also of concern when assessing […]
Presented by: Rene Marcotte, Life Sciences, Senior Vice President, Delivery and Practice Management, RCM Technologies Artificial Intelligence (AI) has rapidly evolved from potential to reality. As organizations seek to leverage AI for process optimization and competitive advantage, the importance of data quality and governance has become paramount. AI’s ability to learn and make accurate decisions […]
Presenter:Karen Taylor (née Ginsbury) is a GMP and Quality Management Systems consultant with over 30 years of industry experience. She has supported both large and small start-up companies in regulatory inspection readiness, handling, and post-inspection responses. Having conducted hundreds of CDMO audits, Karen brings a wealth of case studies to share with participants. Formerly active […]
This forward-looking discussion dives into how AI is transforming validation workflows in the medical device space. Discover how companies are using machine learning and automation to drive speed, accuracy, and regulatory compliance—all without compromising quality. Tune in for actionable insights that will prepare you to integrate digital solutions into your validation process. What You’ll Gain: […]
